Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00290927

First received: February 10, 2006

Last updated: August 25, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 10, 2006

Last Updated Date

August 25, 2009

Start Date ^ICMJE

December 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Efficacy: change in HbA1C from baseline to endpoint (superiority of HMR1964 and OHA combination therapy as compared to OHA therapy, superiority of HMR1964 mono-therapy as compared to OHA therapy)
Safety of HMR1964

Original Primary Outcome Measures ^ICMJE

- Superiority in the efficacy of HMR1964 and OHA combination therapy as compared with OHA therapy in terms of the change in HbA1C from baseline to endpoint.
- Safety of HMR1964.
- Superiority in the efficacy of HMR1964 mono-therapy as compared with OHA therapy in terms of the change in HbA1C from baseline to endpoint.

Change History

Complete list of historical versions of study NCT00290927 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

change in HbA1C from baseline to week 16,consecutive change in HbA1C every 4 wks,plasma glucose parameters, symptomatic hypoglycemia (comparison of HMR1964 intensive therapy, mono-or OHA combination therapy, with OHA therapy).

Original Secondary Outcome Measures ^ICMJE

- Comparison of HMR1964 intensive therapy (mono- or OHA combination therapy) with OHA therapy in terms of the change in HbA1C from baseline to week 16, consecutive change in HbA1C by every 4 weeks, plasma glucose parameters, symptomatic hypoglycemia.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus

Official Title ^ICMJE

Evaluation of Efficacy and Safety of HMR1964 Intensive Therapy in Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled With Oral Hypoglycemic Agents (OHA); OHA Therapy Controlled, Open, Randomized, Parallel Group, Comparative (Superiority), 16-week, Multinational, Multicenter Study

Brief Summary

To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as compared with OHA therapy.
To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA therapy.
To evaluate the safety of HMR1964.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: insulin glulisine

Study Arm (s)

Not Provided

Publications *

Kawamori R, Iwamoto Y, Kadowaki T, Iwasaki M, Kim SW, Woo JT, Baik SH, Yoon KH. Effects of insulin glulisine as mono- or add-on therapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 Jul 13; [Epub ahead of print]

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

390

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Men or women with type 2 diabetes mellitus diagnosed at least one year prior to the study with a BMI < 30 kg/m2 , a HbA1C of > 8.0 - < 11.0% at screening
Fasting serum C-peptide at screening > 0.7 ng/mL
Subjects who have been on a stable regimen and at the following doses of SU for at least 8 weeks prior to signing informed consent
Glibenclamide > 5 mg/day
Glimepiride > 3 mg/day
Gliclazide > 80 mg/day In addition to receiving the above mentioned SU agents, subjects may have been treated with a biguanide at a stable dose for at least 8 weeks prior to signing informed consent.
Subjects willing to administer three HMR1964 injections per day immediately prior to meals for a 16 week

Exclusion Criteria:

Subjects unwilling or incapable of receiving a starting dose of ≥ 0.2 IU/kg/day of HMR1964
Subjects with the likelihood of requiring concomitant treatment during the study period with the following classes of drugs: additional OHA (including thiazolidinediones, α-glucosidase inhibitors, D-phenylalanine derivative) other than those specified in the study protocol, insulin preparations other than HMR1964, systemic corticosteroids, other investigational products
Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine diseases; and active cancer; or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
Subjects who are pregnant, breast feeding or wish to become pregnant during the study period
Subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 12 weeks prior to informed consent, who are expected to have these surgical treatments during the study period, or who were diagnosed newly proliferative diabetic retinopathy within 12 weeks prior to informed consent

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00290927

Other Study ID Numbers ^ICMJE

EFC6168

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Masayoshi KOYAMA

Sanofi

Information Provided By

Sanofi

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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